Clinical Study About Fat Measurement on Multifunction Keito by Comparison Versus Its Predicate K014009
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Purpose
The researchers believe that the multifunction Keito devices shares with TANITA TBF-300 (K014009) the same efficacy on the body fat measurement. Even if the body contact points are not the same, the researchers deeply believe that the tetrapolar BIA used by the predicate gives results as similar as the multifunction keito does.
| Condition |
|---|
|
Body Fat |
| Study Type: | Observational |
| Study Design: | Observational Model: Ecologic or Community Time Perspective: Cross-Sectional |
| Estimated Enrollment: | 177 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | October 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
177 volunteers were enrolled in this clinical Study. Before taking the fat measurement by the devices under test, the observers measured the weight and height of each volunteer prior to measure the body fat. This was done to configure a preliminary idea about the body composition of the subject.
Both devices are designed by the same technology to emit a low current through the body, and finally make a measurement of the impedance found between the body contact points. We expected the results to be very similar.
Eligibility| Ages Eligible for Study: | 18 Years to 82 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
To include the maximum types of patients, the selection was opened to all the general public who could use the multifunction Keito in a public site, where is is intended to be placed. The test was carried out following the user's manual rules about who can use the device.
Inclusion Criteria:
- All population who meet with the requirements described on the user's manual.
Exclusion Criteria:
- Pregnant women.
- Individuals who have a pacemaker or any other internal medical device.
- Population whose weight is under 15 Kg and less than 135 cm tall.
Contacts and Locations| Spain | |
| Aguiflai Iberica, s.l | |
| Vilassar de Mar, Barcelona, Spain, 08340 | |
| Principal Investigator: | Angel P Ferre, Telecommunications Engineer | Aguiflai Iberica, S.L. |
More Information
No publications provided
| Responsible Party: | Angel Pons ferre, Aguiflai Iberica, S.L. |
| ClinicalTrials.gov Identifier: | NCT01360619 History of Changes |
| Other Study ID Numbers: | K8-FAT-05062007 |
| Study First Received: | May 24, 2011 |
| Last Updated: | May 24, 2011 |
| Health Authority: | Spain: Agencia Española de Medicamentos y Productos Sanitarios |
Keywords provided by Aguiflai Iberica, S.L.:
|
To demonstrate that multifunction Keito is as effective, as safe and accurate as the predicate K014009 on its body fat measurement. |
ClinicalTrials.gov processed this record on May 22, 2013